I M, Inc.
Fairfield, NJ, US
I M, Inc. appears in FDA device records in Fairfield, NJ. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for I M, Inc. between 1984 and 1992. The busiest year on record is 1985, with 5. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1985 | 5 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | HBA | Substantially Equivalent | |
| K892389 | BIOPSY KIT | LRO | Unknown | |
| K881363 | SYRINGE PREFILLED WITH WATER | KOD | Substantially Equivalent | |
| K880753 | UMBILICAL CORD CLAMP | HFW | Substantially Equivalent | |
| K872741 | NUTRIPUMP | FRN | Substantially Equivalent | |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | NAD | Substantially Equivalent | |
| K863785 | MAKLER CATHETER | HDR | Substantially Equivalent | |
| K854155 | STERILE SALINE SOLUTION | KMJ | Substantially Equivalent | |
| K853287 | HUBOUT | FPA | Substantially Equivalent | |
| K853288 | FEEDING UNITS & TUBES | KNT | Substantially Equivalent | |
| K853286 | STAPLE REMOVER | Substantially Equivalent | ||
| K844062 | FORCEPS & HAMOSTATS | GEN | Substantially Equivalent | |
| K844063 | SCISSORS GENERAL HOSPITAL | Substantially Equivalent | ||
| K844152 | HEMSTATS | HRQ | Substantially Equivalent | |
| K844151 | SETS AND TRAYS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HDRCap, Cervical
- KODCatheter, Urological
- HFWClamp, Umbilical
- NADDressing, Wound, Occlusive
- GENForceps, General & Plastic Surgery
- LROGeneral Surgery Tray
- HRQHemostat
- KMJLubricant, Patient
- HBANeurosurgical Paddie
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain